How to read the money
Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
Establishing the budget for the United States Government for fiscal year 2014 and setting forth appropriate budgetary levels for fiscal years 2015 through 2023.
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.Con.Res. 25 - Fiscal 2014 House Budget Resolution - Provisions relating to Part D, funding for all government agencies (FDA, HHS, PTO, Homeland Security, DOD, USTR)H.J.Res. 117 - FY 13 Continuing Appropriations Act - Provisions related to sequester implementation, FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting H.R. 933 - FY 13 Consolidated and Further Continuing Appropriations Act - Provisions related to sequester implementation, FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting S.Con.Res. 8 - FY 2014 Senate Budget Resolution - Provisions relating to Part D, funding for all government agencies (FDA, HHS, PTO, Homeland Security, DOD, USTR)
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2013 · first_quarter · Q1
S. 214 - The Preserve Access to Affordable Generics Act - Provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act - Provisions related to patent settlements No bill # assigned - Biopharmaceutical innovation policy issues
No bill # assigned - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccines H.R. 307, S. 242 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologiesS. 610, H.R. 1248 - Family Healthcare Flexibility Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues
Source: Senate LDA
Providing for the appointment of Michael Lynton as a citizen regent of the Board of Regents of the Smithsonian Institution.
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.Con.Res. 25 - Fiscal 2014 House Budget Resolution - Provisions relating to Part D, funding for all government agencies (FDA, HHS, PTO, Homeland Security, DOD, USTR)H.J.Res. 117 - FY 13 Continuing Appropriations Act - Provisions related to sequester implementation, FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting H.R. 933 - FY 13 Consolidated and Further Continuing Appropriations Act - Provisions related to sequester implementation, FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting S.Con.Res. 8 - FY 2014 Senate Budget Resolution - Provisions relating to Part D, funding for all government agencies (FDA, HHS, PTO, Homeland Security, DOD, USTR)
Family Health Care Flexibility Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
No bill # assigned - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccines H.R. 307, S. 242 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologiesS. 610, H.R. 1248 - Family Healthcare Flexibility Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
No bill # assigned - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccines H.R. 307, S. 242 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologiesS. 610, H.R. 1248 - Family Healthcare Flexibility Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues
Protecting Seniors' Access to Medicare Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013 H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013 - provisions related to Medicare Part D S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013S. 408- Medicare Prescription Drug Savings and Choice Act of 2013 - provisions related to Medicare Part D No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues - provisions related to Medicare No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act
Medicare Prescription Drug Savings and Choice Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013 H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013 - provisions related to Medicare Part D S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013S. 408- Medicare Prescription Drug Savings and Choice Act of 2013 - provisions related to Medicare Part D No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues - provisions related to Medicare No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act
Medicare Prescription Drug Price Negotiation Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013 H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013 - provisions related to Medicare Part D S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013S. 408- Medicare Prescription Drug Savings and Choice Act of 2013 - provisions related to Medicare Part D No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues - provisions related to Medicare No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act
Preserve Access to Affordable Generics Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 214 - The Preserve Access to Affordable Generics Act - Provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act - Provisions related to patent settlements No bill # assigned - Biopharmaceutical innovation policy issues
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
No bill # assigned - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccines H.R. 307, S. 242 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologiesS. 610, H.R. 1248 - Family Healthcare Flexibility Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Pharmaceutical supply chain security issues No bill # assigned - 340B policy issues
FAIR Generics Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 214 - The Preserve Access to Affordable Generics Act - Provisions relating to patent settlements S. 504 - Fair and Immediate Release of Generic Drugs Act - Provisions related to patent settlements No bill # assigned - Biopharmaceutical innovation policy issues
American Taxpayer Relief Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 8 - American Taxpayer Relief Act of 2012 (112th Congress) - provisions related to Medicare and Tax No bill # assigned - "Temporary duty suspension for preparations, such as tablets or chewing gum, intended to assist smokers to stop smoking (provided for in subheading 2106.90.99) "S. 391, H.R. 475 - To amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Strengthening Medicare And Repaying Taxpayers Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates H.R.999 - Medicare Prescription Drug Savings and Choice Act of 2011 - provisions related to Medicare Part D H.R.2190 - Medicare Drug Savings Act of 2011 - provisions related to Medicare Part D H.R.452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) S.668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S.1206 - Medicare Prescription Drug Savings Act of 2011 - provisions related to Medicare Part D S.1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R.1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Strengthening Medicare And Repaying Taxpayers Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 5 - Protecting Access to Healthcare Act, provisions related to Independent Payment Advisory Board (IPAB) H.R. 8 - American Taxpayer Relief Act of 2012, provisions related to Medicare and tax H.R. 452 - Medicare Decisions Accountability Act, provisions related to the Independent Payment Advisory Board (IPAB) H.R. 999 - Medicare Prescription Drug Savings and Choice Act of 2011, provisions related to Medicare Part D H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011, provisions relating to reform of Secondary Payer rules H.R. 1845 - Medicare IVIG Access Act, provisions relating to reform of Secondary Payer rules H.R. 2190 - Medicare Drug Savings Act of 2011, provisions related to Medicare Part D S. 365- Budget Control Act of 2011, Deficit reduction issues related to Medicare and Medicaid S. 668 - Health Care Bureaucrats Elimination Act, provisions related to the Independent Payment Advisory Board (IPAB) S. 1206 - Medicare Prescription Drug Savings Act of 2011, provisions related to Medicare Part D S. 1251 - Medicare and Medicaid FAST Act, provisions related to Part D issues S. 1699 - Prescription Drug Cost Reduction Act, provisions related to Medicare Part B and drug rebates Dual eligibles coordination policy issues Deficit reduction policy issues Medicaid program, Covered Outpatient Drugs rulemaking Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Strengthening Medicare And Repaying Taxpayers Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates HR 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 - Medicare Prescription Drug Price Negotiation Act of 2011- provision related to Medicare Part D HR 3765 - Temporary Payroll Tax Cut Continuation Act of 2011- provisions related to Medicare S 31 - Prescription Drug and Health Improvement Act of 2011-provisions related to Medicare Part D S 44 - Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) H.R. 5 - To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system - provisions related to the Independent Payment Advisory Board (IPAB) S 560 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules S 365 - Budget Control Act of 2011 - provisions related to deficit reduction through Medicare and Medicaid
Strengthening Medicare And Repaying Taxpayers Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates HR 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 - Medicare Prescription Drug Price Negotiation Act of 2011- provision related to Medicare Part D HR 3765 - Temporary Payroll Tax Cut Continuation Act of 2011- provisions related to Medicare S 31 - Prescription Drug and Health Improvement Act of 2011-provisions related to Medicare Part D S 44 - Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) H.R. 5 - To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system - provisions related to the Independent Payment Advisory Board (IPAB) S 560 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules S 365 - Budget Control Act of 2011 - provisions related to deficit reduction through Medicare and Medicaid
Strengthening Medicare And Repaying Taxpayers Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates H.R. 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D H.R. 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D H.R. 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) S. 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S. 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S. 1251 -Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011- provisions relating to reform of Secondary Payer rules No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Drug Safety Enhancement Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Drug Safety Enhancement Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Drug Safety Enhancement Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Drug Safety Enhancement Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Great Ape Protection and Cost Savings Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines
Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 5 - Protecting Access to Healthcare Act, provisions related to Independent Payment Advisory Board (IPAB) H.R. 8 - American Taxpayer Relief Act of 2012, provisions related to Medicare and tax H.R. 452 - Medicare Decisions Accountability Act, provisions related to the Independent Payment Advisory Board (IPAB) H.R. 999 - Medicare Prescription Drug Savings and Choice Act of 2011, provisions related to Medicare Part D H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011, provisions relating to reform of Secondary Payer rules H.R. 1845 - Medicare IVIG Access Act, provisions relating to reform of Secondary Payer rules H.R. 2190 - Medicare Drug Savings Act of 2011, provisions related to Medicare Part D S. 365- Budget Control Act of 2011, Deficit reduction issues related to Medicare and Medicaid S. 668 - Health Care Bureaucrats Elimination Act, provisions related to the Independent Payment Advisory Board (IPAB) S. 1206 - Medicare Prescription Drug Savings Act of 2011, provisions related to Medicare Part D S. 1251 - Medicare and Medicaid FAST Act, provisions related to Part D issues S. 1699 - Prescription Drug Cost Reduction Act, provisions related to Medicare Part B and drug rebates Dual eligibles coordination policy issues Deficit reduction policy issues Medicaid program, Covered Outpatient Drugs rulemaking Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Access to Appropriate Immunizations for Veterans Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Access to Appropriate Immunizations for Veterans Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Access to Appropriate Immunizations for Veterans Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Access to Appropriate Immunizations for Veterans Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Access to Appropriate Immunizations for Veterans Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines
Generating Antibiotic Incentives Now Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements H.R. 3995 - Protect Consumer Access to Generic Drugs Act - provisions related to patent settlements HR 3497 - MODERN Cures Act of 2011 - provisions related to data protection S.27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics H.R. 2182, S.1734 - Generating Antibiotic Incentives Now Act of 2011 - implementation of provisions related to antibiotics and incentives S.373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S. 1882 - The Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements No bill # assigned - International intellectual property issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Technical corrections to the America Invents Act
Generating Antibiotic Incentives Now Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements H.R. 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S. 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics H.R. 2182,S. 1734 - Generating Antibiotic Incentives Now Act of 2011 - provisions related to antibiotics and incentives H.R. 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S. 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S. 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting No bill # assigned - International intellectual property issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Technical corrections to the America Invents Act
Generating Antibiotic Incentives Now Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
HR 3995 - Protect Consumers Access to Generic Drugs Act - provisions related to patent settlements S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements HR 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting HR 2182,S 1734 - Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives
Generating Antibiotic Incentives Now Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
HR 3995 - Protect Consumers Access to Generic Drugs Act - provisions related to patent settlements S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements HR 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting HR 2182,S 1734 - Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives
Medicare Drug Savings Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates HR 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 - Medicare Prescription Drug Price Negotiation Act of 2011- provision related to Medicare Part D HR 3765 - Temporary Payroll Tax Cut Continuation Act of 2011- provisions related to Medicare S 31 - Prescription Drug and Health Improvement Act of 2011-provisions related to Medicare Part D S 44 - Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) H.R. 5 - To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system - provisions related to the Independent Payment Advisory Board (IPAB) S 560 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules S 365 - Budget Control Act of 2011 - provisions related to deficit reduction through Medicare and Medicaid
Medicare Drug Savings Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates H.R.999 - Medicare Prescription Drug Savings and Choice Act of 2011 - provisions related to Medicare Part D H.R.2190 - Medicare Drug Savings Act of 2011 - provisions related to Medicare Part D H.R.452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) S.668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S.1206 - Medicare Prescription Drug Savings Act of 2011 - provisions related to Medicare Part D S.1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R.1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Medicare Drug Savings Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates H.R. 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D H.R. 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D H.R. 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) S. 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S. 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S. 1251 -Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011- provisions relating to reform of Secondary Payer rules No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Medicare Drug Savings Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 5 - Protecting Access to Healthcare Act, provisions related to Independent Payment Advisory Board (IPAB) H.R. 8 - American Taxpayer Relief Act of 2012, provisions related to Medicare and tax H.R. 452 - Medicare Decisions Accountability Act, provisions related to the Independent Payment Advisory Board (IPAB) H.R. 999 - Medicare Prescription Drug Savings and Choice Act of 2011, provisions related to Medicare Part D H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011, provisions relating to reform of Secondary Payer rules H.R. 1845 - Medicare IVIG Access Act, provisions relating to reform of Secondary Payer rules H.R. 2190 - Medicare Drug Savings Act of 2011, provisions related to Medicare Part D S. 365- Budget Control Act of 2011, Deficit reduction issues related to Medicare and Medicaid S. 668 - Health Care Bureaucrats Elimination Act, provisions related to the Independent Payment Advisory Board (IPAB) S. 1206 - Medicare Prescription Drug Savings Act of 2011, provisions related to Medicare Part D S. 1251 - Medicare and Medicaid FAST Act, provisions related to Part D issues S. 1699 - Prescription Drug Cost Reduction Act, provisions related to Medicare Part B and drug rebates Dual eligibles coordination policy issues Deficit reduction policy issues Medicaid program, Covered Outpatient Drugs rulemaking Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Medicare Drug Savings Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates HR 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 - Medicare Prescription Drug Price Negotiation Act of 2011- provision related to Medicare Part D HR 3765 - Temporary Payroll Tax Cut Continuation Act of 2011- provisions related to Medicare S 31 - Prescription Drug and Health Improvement Act of 2011-provisions related to Medicare Part D S 44 - Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) H.R. 5 - To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system - provisions related to the Independent Payment Advisory Board (IPAB) S 560 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules S 365 - Budget Control Act of 2011 - provisions related to deficit reduction through Medicare and Medicaid
Preserving Access to Life-Saving Medications Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Preserving Access to Life-Saving Medications Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Preserving Access to Life-Saving Medications Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Preserving Access to Life-Saving Medications Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Preserving Access to Life-Saving Medications Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines
Medicare Prescription Drug Price Negotiation Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates HR 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 - Medicare Prescription Drug Price Negotiation Act of 2011- provision related to Medicare Part D HR 3765 - Temporary Payroll Tax Cut Continuation Act of 2011- provisions related to Medicare S 31 - Prescription Drug and Health Improvement Act of 2011-provisions related to Medicare Part D S 44 - Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) H.R. 5 - To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system - provisions related to the Independent Payment Advisory Board (IPAB) S 560 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules S 365 - Budget Control Act of 2011 - provisions related to deficit reduction through Medicare and Medicaid
Medicare Prescription Drug Price Negotiation Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates HR 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 - Medicare Prescription Drug Price Negotiation Act of 2011- provision related to Medicare Part D HR 3765 - Temporary Payroll Tax Cut Continuation Act of 2011- provisions related to Medicare S 31 - Prescription Drug and Health Improvement Act of 2011-provisions related to Medicare Part D S 44 - Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) H.R. 5 - To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system - provisions related to the Independent Payment Advisory Board (IPAB) S 560 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules S 365 - Budget Control Act of 2011 - provisions related to deficit reduction through Medicare and Medicaid
Pandemic and All-Hazards Preparedness Reauthorization Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Pandemic and All-Hazards Preparedness Reauthorization Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Pandemic and All-Hazards Preparedness Reauthorization Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Pandemic and All-Hazards Preparedness Reauthorization Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Pandemic and All-Hazards Preparedness Reauthorization Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines
Restoring Access to Medication Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Restoring Access to Medication Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Restoring Access to Medication Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Restoring Access to Medication Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Restoring Access to Medication Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines
340B Program Improvement Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines
340B Program Improvement Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
340B Program Improvement Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
340B Program Improvement Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
340B Program Improvement Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Budget Control Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. Res. 117 - Fiscal 2013 Continuing Appropriations Resolution S. 3295 - Fiscal Year 2013 Labor-HHS-Education Appropriations Act - provisions relating to Vaccine Section 317 program, Ryan White CARE Act H.R. 2693 - Budget Control Act of 2011 - sequestration implementation
Budget Control Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.J. Res. 117 - Fiscal 2013 Continuing Appropriations Resolution, provisions relating to FDA funding, Vaccine Section 317 program, Ryan White CARE Act, BARDA funding, ACA implementation funding, 340B, IPAP H.R. 2693 - Budget Control Act of 2011, sequestration implementation
Pharmaceutical Stewardship Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Pharmaceutical Stewardship Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Pharmaceutical Stewardship Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Pharmaceutical Stewardship Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Guidance Accountability and Transparency Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Guidance Accountability and Transparency Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Food and Drug Administration Mission Reform Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Food and Drug Administration Mission Reform Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Food and Drug Administration Mission Reform Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Stop Online Piracy Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
HR 3995 - Protect Consumers Access to Generic Drugs Act - provisions related to patent settlements S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements HR 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting HR 2182,S 1734 - Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives
Stop Online Piracy Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
HR 3995 - Protect Consumers Access to Generic Drugs Act - provisions related to patent settlements S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements HR 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting HR 2182,S 1734 - Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives
Stop Online Piracy Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements H.R. 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S. 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics H.R. 2182,S. 1734 - Generating Antibiotic Incentives Now Act of 2011 - provisions related to antibiotics and incentives H.R. 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S. 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S. 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting No bill # assigned - International intellectual property issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Technical corrections to the America Invents Act
MODDERN Cures Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements H.R. 3995 - Protect Consumer Access to Generic Drugs Act - provisions related to patent settlements HR 3497 - MODERN Cures Act of 2011 - provisions related to data protection S.27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics H.R. 2182, S.1734 - Generating Antibiotic Incentives Now Act of 2011 - implementation of provisions related to antibiotics and incentives S.373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S. 1882 - The Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements No bill # assigned - International intellectual property issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Technical corrections to the America Invents Act
MODDERN Cures Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements H.R. 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S. 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics H.R. 2182,S. 1734 - Generating Antibiotic Incentives Now Act of 2011 - provisions related to antibiotics and incentives H.R. 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S. 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S. 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting No bill # assigned - International intellectual property issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Technical corrections to the America Invents Act
MODDERN Cures Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
HR 3995 - Protect Consumers Access to Generic Drugs Act - provisions related to patent settlements S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements HR 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting HR 2182,S 1734 - Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives
MODDERN Cures Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
HR 3995 - Protect Consumers Access to Generic Drugs Act - provisions related to patent settlements S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements HR 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting HR 2182,S 1734 - Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives
Temporary Payroll Tax Cut Continuation Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates HR 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 - Medicare Prescription Drug Price Negotiation Act of 2011- provision related to Medicare Part D HR 3765 - Temporary Payroll Tax Cut Continuation Act of 2011- provisions related to Medicare S 31 - Prescription Drug and Health Improvement Act of 2011-provisions related to Medicare Part D S 44 - Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) H.R. 5 - To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system - provisions related to the Independent Payment Advisory Board (IPAB) S 560 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules S 365 - Budget Control Act of 2011 - provisions related to deficit reduction through Medicare and Medicaid
Temporary Payroll Tax Cut Continuation Act of 2011
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates HR 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 - Medicare Prescription Drug Price Negotiation Act of 2011- provision related to Medicare Part D HR 3765 - Temporary Payroll Tax Cut Continuation Act of 2011- provisions related to Medicare S 31 - Prescription Drug and Health Improvement Act of 2011-provisions related to Medicare Part D S 44 - Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) H.R. 5 - To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system - provisions related to the Independent Payment Advisory Board (IPAB) S 560 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules S 365 - Budget Control Act of 2011 - provisions related to deficit reduction through Medicare and Medicaid
Drug Shortage Prevention Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Drug Shortage Prevention Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Drug Shortage Prevention Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
Drug Shortage Prevention Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Protecting Consumer Access to Generic Drugs Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements H.R. 3995 - Protect Consumer Access to Generic Drugs Act - provisions related to patent settlements HR 3497 - MODERN Cures Act of 2011 - provisions related to data protection S.27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics H.R. 2182, S.1734 - Generating Antibiotic Incentives Now Act of 2011 - implementation of provisions related to antibiotics and incentives S.373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S. 1882 - The Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements No bill # assigned - International intellectual property issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Technical corrections to the America Invents Act
Protecting Consumer Access to Generic Drugs Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs, provisions relating to authorized generics H.R. 3995 - Protect Consumer Access to Generic Drugs Act, provisions related to patent settlements H.R. 6621 - A bill to make technical corrections to the America Invents Act S. 27 - Preserve Access to Affordable Generics Act, provisions related to patent settlements S. 373 - The Fair Prescription Drug Competition Act, provisions related to authorized generics S. 1882 - Fair and Immediate Release of Generic Drugs Act, provisions related to patent settlements International intellectual property issues Biopharmaceutical innovation policy issues
Protecting Consumer Access to Generic Drugs Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
HR 3995 - Protect Consumers Access to Generic Drugs Act - provisions related to patent settlements S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements HR 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting HR 2182,S 1734 - Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives
Protecting Consumer Access to Generic Drugs Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
HR 3995 - Protect Consumers Access to Generic Drugs Act - provisions related to patent settlements S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements HR 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting HR 2182,S 1734 - Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives
H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
EXPERRT Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines
EXPERRT Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
EXPERRT Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
EXPERRT Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
EXPERRT Act of 2012
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
SAFE DOSES Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines
SAFE DOSES Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
SAFE DOSES Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
SAFE DOSES Act
Client: GSK (FKA GLAXOSMITHKLINE INC.) · Firm: GSK (FKA GLAXOSMITHKLINE INC.)
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
H.R. 8 - American Taxpayer Relief Act of 2012 (112th Congress) - provisions related to Medicare and Tax No bill # assigned - "Temporary duty suspension for preparations, such as tablets or chewing gum, intended to assist smokers to stop smoking (provided for in subheading 2106.90.99) "S. 391, H.R. 475 - To amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
No bill # assigned - Trans-Pacific Strategic Economic Partnership Agreement (TPP)provisions related to intellectual property, market access and public health No bill # assigned - Mexico and Canada IP and market access issues in context of invitation to join TPP negotiations No bill # assigned - EU/US trade liberalizing agreementNo bill # assigned - International market access and intellectual property issues
H.R. 351 - Protecting Seniors' Access to Medicare Act of 2013 H.R. 928 - Medicare Prescription Drug Savings and Choice Act of 2013 - provisions related to Medicare Part D S. 117 - Medicare Prescription Drug Price Negotiation Act of 2013S. 408- Medicare Prescription Drug Savings and Choice Act of 2013 - provisions related to Medicare Part D No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues - provisions related to Medicare No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Implementation Issues relating to the Physician Payment Sunshine Act
H.Con.Res. 25 - Fiscal 2014 House Budget Resolution - Provisions relating to Part D, funding for all government agencies (FDA, HHS, PTO, Homeland Security, DOD, USTR)H.J.Res. 117 - FY 13 Continuing Appropriations Act - Provisions related to sequester implementation, FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting H.R. 933 - FY 13 Consolidated and Further Continuing Appropriations Act - Provisions related to sequester implementation, FDA funding, oversight, trade, prescription drug abuse, comparative effectiveness research, NIH funding, BARDA funding, PPACA implementation funding, 340B, IPAB, defense health accounts, biodefense funding/projects, and defense contracting S.Con.Res. 8 - FY 2014 Senate Budget Resolution - Provisions relating to Part D, funding for all government agencies (FDA, HHS, PTO, Homeland Security, DOD, USTR)
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2012 · fourth_quarter · Q4
H.R. 5 - Protecting Access to Healthcare Act, provisions related to Independent Payment Advisory Board (IPAB) H.R. 8 - American Taxpayer Relief Act of 2012, provisions related to Medicare and tax H.R. 452 - Medicare Decisions Accountability Act, provisions related to the Independent Payment Advisory Board (IPAB) H.R. 999 - Medicare Prescription Drug Savings and Choice Act of 2011, provisions related to Medicare Part D H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011, provisions relating to reform of Secondary Payer rules H.R. 1845 - Medicare IVIG Access Act, provisions relating to reform of Secondary Payer rules H.R. 2190 - Medicare Drug Savings Act of 2011, provisions related to Medicare Part D S. 365- Budget Control Act of 2011, Deficit reduction issues related to Medicare and Medicaid S. 668 - Health Care Bureaucrats Elimination Act, provisions related to the Independent Payment Advisory Board (IPAB) S. 1206 - Medicare Prescription Drug Savings Act of 2011, provisions related to Medicare Part D S. 1251 - Medicare and Medicaid FAST Act, provisions related to Part D issues S. 1699 - Prescription Drug Cost Reduction Act, provisions related to Medicare Part B and drug rebates Dual eligibles coordination policy issues Deficit reduction policy issues Medicaid program, Covered Outpatient Drugs rulemaking Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
H.R. 942 - American Research and Competitiveness Act of 2011, provisions relating to the research and development tax credit S. 3144 - Temporary duty suspension for Preparations, such as tablets or chewing gum, intended to assist smokers to stop smoking (provided for in subheading 2106.90.99)
H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs, provisions relating to authorized generics H.R. 3995 - Protect Consumer Access to Generic Drugs Act, provisions related to patent settlements H.R. 6621 - A bill to make technical corrections to the America Invents Act S. 27 - Preserve Access to Affordable Generics Act, provisions related to patent settlements S. 373 - The Fair Prescription Drug Competition Act, provisions related to authorized generics S. 1882 - Fair and Immediate Release of Generic Drugs Act, provisions related to patent settlements International intellectual property issues Biopharmaceutical innovation policy issues
H.J. Res. 117 - Fiscal 2013 Continuing Appropriations Resolution, provisions relating to FDA funding, Vaccine Section 317 program, Ryan White CARE Act, BARDA funding, ACA implementation funding, 340B, IPAP H.R. 2693 - Budget Control Act of 2011, sequestration implementation
H.R. 1513 and S.810 - Great Ape Protection and Cost Savings Act, provisions related to pre-clinical testing H.R. 1930 and S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011, provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011, provisions related to drug shortages H.R. 2405 and S. 1855 - Pandemic and All Hazards Preparedness Act, provisions relating to influenza vaccine innovative technologies H.R. 2529 and S. 1368 - Restoring Access to Medication Act, provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts H.R. 2674 - 340B Program Improvement Act, provisions related to the 340B program H.R. 4132 - FAST Act, provisions related to accelerated approval and other FDA matters H.R. 4156 amd S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012, provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 4223 and S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES), provisions related to supply chain security H.R. 4274 - BPCA and PREA Reauthorization Act of 2012, Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 5651 - Food and Drug Administration Reform Act of 2012, provisions related to user fee reauthorization and FDA reform H.R. 6190 - Asthma Inhalers Relief Act of 2012, provisions relating to the removal of Essential-Use Designation for epinephrine H.R. 6611 - Patients Access to Drugs in Shortage Act of 2012, provisions to promote public notification and provide incentives to reduce drug shortages S. 1584 - Drug Safety and Accountability Act of 2011, provisions related to drug safety S. 1699- Prescription Drug Cost Reduction Act, provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011, provisions relating to the removal of Essential-Use Designation for epinephrine S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act, provisions related to accelerated approval and other FDA matters S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012, provisions related to FDA regulation S. 2281 - Expanding and Promoting Expertise in Rare Treatments Act, provisions related to FDA regulation S. 2289 - The Better Pharmaceuticals and Devices for Children Act, provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012, provisions related to user fee reauthorization and FDA reform PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act, ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions Federal Food, Drug, and Cosmetic Act, section related to FDA and regulation of nicotine replacement therapies Comparative effectiveness policy issues H.R. 6687, To amend the Internal Revenue Code of 1986 to include vaccines against seasonal influenza within the definition of taxable vaccines
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR), White House Office
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2012 · third_quarter · Q3
No bill # assigned - Trans-Pacific Strategic Economic Partnership Agreement (TPP) - provisions related to intellectual property, market access and public health H.R.6083 - Federal Agriculture Reform and Risk Management Act of 2012 - provisions related to WTO Brazil Cotton dispute S.3240 - Agriculture Reform, Food and Jobs Act of 2012 - provisions related to WTO Brazil cotton dispute No bill # assigned - Mexico and Canada IP and market access issues in context of invitation to join TPP negotiations No bill # assigned - EU/US trade liberalizing agreement No bill # assigned - International market access and intellectual property issues
H.R. Res. 117 - Fiscal 2013 Continuing Appropriations Resolution S. 3295 - Fiscal Year 2013 Labor-HHS-Education Appropriations Act - provisions relating to Vaccine Section 317 program, Ryan White CARE Act H.R. 2693 - Budget Control Act of 2011 - sequestration implementation
S.3144 - "Temporary duty suspension for Preparations, such as tablets or chewing gum, intended to assist smokers to stop smoking (provided for in subheading 2106.90.99) " H.R.942 - American Research and Competitiveness Act of 2011 - provisions relating to the research and development tax credit
S.2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S.2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R.4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R.4156, S.2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R.4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R.3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R.2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R.2405, S.1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R.4223, S.1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) provisions related to supply chain security H.R.1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security H.R.1930, S.1799 - Access to Appropriate Immunizations for Veterans Act of 2011 - provisions related to extending VA performance measure to include all federally recommended vaccine H.R.3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment H.R.2245, S.296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R.2939 - Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety H.R.5651 - Food and Drug Administration Reform Act of 2012 - provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R.2529, S.1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S.1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S.1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R.3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance S.810 - Great Ape Protection and Cost Savings Act of 2011 - provisions related to pre-clinical testing H.R.6190 - Asthma Inhalers Relief Act of 2012 - provisions relating to the removal of Essential-Use Designation for epinephrine S.1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine No bill # assigned - Comparative effectiveness policy issues No bill # assigned - Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
S.1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates H.R.999 - Medicare Prescription Drug Savings and Choice Act of 2011 - provisions related to Medicare Part D H.R.2190 - Medicare Drug Savings Act of 2011 - provisions related to Medicare Part D H.R.452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) S.668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S.1206 - Medicare Prescription Drug Savings Act of 2011 - provisions related to Medicare Part D S.1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R.1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements H.R. 3995 - Protect Consumer Access to Generic Drugs Act - provisions related to patent settlements HR 3497 - MODERN Cures Act of 2011 - provisions related to data protection S.27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics H.R. 2182, S.1734 - Generating Antibiotic Incentives Now Act of 2011 - implementation of provisions related to antibiotics and incentives S.373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S. 1882 - The Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements No bill # assigned - International intellectual property issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Technical corrections to the America Invents Act
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2012 · first_quarter · 1A
Trans-Pacific Strategic Economic Partnership Agreement (TPP) - provisions related to intellectual property, market access and public health Russia Permanent Normal Trade Relations (PNTR) - "provisions related to lifting the restrictions of Title IV of the Trade Act of 1974 as they apply to Russia, which includes the freedom-of-emigration requirements of the Jackson-Vranik amendment."
H.R. 942 - American Research and Competitiveness Act of 2011- provisions relating to the research and development tax credit
S 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates HR 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 - Medicare Prescription Drug Price Negotiation Act of 2011- provision related to Medicare Part D HR 3765 - Temporary Payroll Tax Cut Continuation Act of 2011- provisions related to Medicare S 31 - Prescription Drug and Health Improvement Act of 2011-provisions related to Medicare Part D S 44 - Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) H.R. 5 - To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system - provisions related to the Independent Payment Advisory Board (IPAB) S 560 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules S 365 - Budget Control Act of 2011 - provisions related to deficit reduction through Medicare and Medicaid
Fiscal Year 2013 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act - provisions relating to Ryan White CARE Act, FDA funding Fiscal Year 2013 Department of Homeland Security Appropriations Act - provisions relating to Customs and Border Protection Fiscal Year 2013 Labor-HHS-Education Appropriations Act - provisions relating to Vaccine Section 317 program, Ryan White CARE Act H Con Res 112 Establishing the budget for the United States Government for fiscal year 2013 and setting forth appropriate budgetary levels for fiscal years 2014 through 2022 - provisions related to health care programs
HR 3995 - Protect Consumers Access to Generic Drugs Act - provisions related to patent settlements S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements HR 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting HR 2182,S 1734 - Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2012 · second_quarter · Q2
H.R. 5973, S. 2375 - Fiscal Year 2013 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act - provisions relating to Ryan White CARE Act, FDA funding H.R. 5855, S. 3216 - Fiscal Year 2013 Department of Homeland Security Appropriations Act - provisions relating to Customs and Border Protection S. 3295 - Fiscal Year 2013 Labor-HHS-Education Appropriations Act - provisions relating to Vaccine Section 317 program, Ryan White CARE Act H.R. 5857, S. 3241 - Department of State, Foreign Operations and Related Programs Appropriations Act - provisions related to funding to combat neglected tropical diseases H.R. 4966 - Sequester Replacement Act of 2012 - provisions related to overall healthcare programs, government functions, and Medicare policy changes H.R. 5652 - Sequester Replacement Reconciliation Act of 2012 - provisions related to overall healthcare programs, government functions, and Medicare policy changes
H.R. 942 - American Research and Competitiveness Act of 2011- provisions relating to the research and development tax credit
S. 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S. 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters S. 2289 - The Better Pharmaceuticals and Devices for Children Act - "Provisions related to amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" H.R. 4274 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 4156, S. 2281- Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases H.R. 3214 - Food and Drug Administration Mission Reform Act of 2011 - provisions to revise the mission of the Food and Drug Administration H.R. 4132 - FAST Act - provisions related to accelerated approval and other FDA matters H.R. 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages H.R. 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions H.R. 2405, S. 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies H.R. 4223, S. 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security H.R. 1483 - The Drug Safety Enhancement Act of 2011- provisions related to supply chain security H.R. 1930, S. 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine H.R. 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S. 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation H.R. 2245, S. 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages H.R. 2939 - Pharmaceutical Stewardship Act of 2011-provisions related to drug safety H.R. 5651 - Food and Rug Administration Reform Act of 2012-provisions related to user fee reauthorization and FDA reform S. 3187 - Food and Drug Administration Safety and Innovation Act of 2012 - provisions related to user fee reauthorization and FDA reform H.R. 2529, S. 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S. 1584 - Drug Safety and Accountability Act of 2011 - provisions related to drug safety No bill # assigned - Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates H.R. 3204 - Guidance Accountability and Transparency Act - provisions to set forth interpretation policy of FDA guidance No bill # assigned - USAID Child Survival Call to Action S. 1752 - Freedom to Breathe Act of 2011 -provisions relating to the removal of Essential-Use Designation for epinephrine. No bill # assigned -Efforts to amend the National Childhood Vaccine Injury Act of 1986 (26 USC 4132(N)) to include any vaccine against seasonal influenza.
S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements H.R. 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S. 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics H.R. 2182,S. 1734 - Generating Antibiotic Incentives Now Act of 2011 - provisions related to antibiotics and incentives H.R. 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S. 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S. 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting No bill # assigned - International intellectual property issues No bill # assigned - Biopharmaceutical innovation policy issues No bill # assigned - Technical corrections to the America Invents Act
No bill # assigned - Trans-Pacific Strategic Economic Partnership Agreement (TPP) - provisions related to intellectual property, market access and public health H.R. 6083 - Federal Agriculture Reform and Risk Management Act of 2012 -provisions related to WTO Brazil Cotton dispute S. 3240 - Agriculture Reform, Food and Jobs Act of 2012 - provisions related to WTO Brazil cotton dispute No bill # assigned - Russia Permanent Normal Trade Relations (PNTR) - "provisions related to lifting the restrictions of Title IV of the Trade Act of 1974 as they apply to Russia, which includes the freedom-of-emigration requirements of the Jackson-Vranik amendment." H.R. 6083 - Federal Agriculture Reform and Risk Management Act of 2012 - provisions related to WTO Brazil Cotton dispute S. 3240 - Agriculture Reform, Food and Jobs Act of 2012 - provisions related to WTO Brazil cotton dispute No bill # assigned - Colombia Free Trade Agreement - Implementation issues related to intellectual property, market access and public health
S. 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates H.R. 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D H.R. 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D H.R. 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) S. 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S. 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S. 1251 -Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011- provisions relating to reform of Secondary Payer rules No bill # assigned - Dual eligibles coordination policy issues No bill # assigned - Deficit reduction policy issues No bill # assigned - Medicaid Program, Covered Outpatient Drugs rulemaking No bill # assigned - Medicare, Medicaid, Children's Health Insurance Programs,; Transparency Reports and Reporting of Physician Ownership or Investment Interests rulemaking
Filing targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Natl Security Council (NSC), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2012 · first_quarter · Q1
Trans-Pacific Strategic Economic Partnership Agreement (TPP) - provisions related to intellectual property, market access and public health Russia Permanent Normal Trade Relations (PNTR) - "provisions related to lifting the restrictions of Title IV of the Trade Act of 1974 as they apply to Russia, which includes the freedom-of-emigration requirements of the Jackson-Vranik amendment."
Fiscal Year 2013 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act - provisions relating to Ryan White CARE Act, FDA funding Fiscal Year 2013 Department of Homeland Security Appropriations Act - provisions relating to Customs and Border Protection Fiscal Year 2013 Labor-HHS-Education Appropriations Act - provisions relating to Vaccine Section 317 program, Ryan White CARE Act H Con Res 112 Establishing the budget for the United States Government for fiscal year 2013 and setting forth appropriate budgetary levels for fiscal years 2014 through 2022 - provisions related to health care programs
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2011 · fourth_quarter · Q4
S 27 Preserve Access to Affordable Generics Act - provisions related to patent settlements HR 741 To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 2182,S 1734 Generating Antibiotic Incentives Now Act of 2011 - provisions related to antibiotics and incentives HR 3261 Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting
HR 999Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190Medicare Drug Savings Act of 2011 - provisions related to Medicare Part D HR 2248Medicare Prescription Drug Price Negotiation Act of 2011 - provision related to Medicare Part D H.R. 3765Temporary Payroll Tax Cut Continuation Act of 2011provisions related to Medicare S 31Prescription Drug and Health Improvement Act of 2011- provisions related to Medicare Part D S 44Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) S 365Budget Control Act of 2011 - deficit reduction issues related to Medicare and Medicaid S 560Medicare Prescription Drug Savings and Choice Act of 2011-provisions related to Medicare Part D S 668Health Care Bureaucrats Elimination Actprovisions related to the Independent Payment Advisory Board (IPAB) S 1206 Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 Medicare and Medicaid FAST Act - provisions related to Part D issues HR 1063 Strengthening Medicare & Repaying Taxpayers Act of 2011- provisions relating to reform of Secondary Payer rules
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2011 · third_quarter · Q3
HR 2112 Fiscal Year 2012 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act - provisions pertaining to Ryan White CARE Act, FDA funding HR 2017 The Department of Homeland Security Appropriations Act - provisions pertaining to Customs and Border Protection S 1599 Fiscal Year 2012 Labor - HHS-Education Appropriations -FY 2012 HHS Budget Request; proposal relating to Vaccine Section 317 program, Ryan White CARE Act
PL 111-148, PL 111-152 Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 1930 Access to Appropriate Immunizations for Veterans Act of 2011- extending VA performance measures to include all federally recommended vaccines HR 2405Pandemic and All Hazards Preparedness Act - re-authorization; influenza vaccine innovative technologies S 1002 Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - drug safety HR 1483The Drug Safety Enhancement Act of 2011- drug safety standards HR 2182Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives HR 1930Access to Appropriate Immunizations for Veterans Act of 2011- vaccine access HR 3202Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 Pharmaceutical Market Access and Drug Safety Act of 2011- provisions related to drug importation HR 2245Preserving Access to Life-Savings Medicines Act of 2011- provisions related to drug shortages HR 2939Pharmaceutical Stewardship Act of 2011- provisions related to drug safety S 1584The Drug Safety and Accountability Act of 2011- provisions related to drug safety HR 2529, S 1368 Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts HR 605, S 312 Patients Freedom to Choose Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts ADDENDUM/General Lobbying Issue Area - Federal Food, Drug, and Cosmetic Act (currently unassigned) - section related to FDA and regulation of nicotine replacement therapies ADDENDUM/General Lobbying Issue Area - Prescription Drug User Fee Act (currently unassigned) - issues related to reauthorization of the Prescription Drug User Fee Act
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2011 · second_quarter · Q2
S 23, HR 1249 America Invents Act - provisions related to supplemental examination, first inventor to file, best mode, and false marking
HR 942 American Research and Competitiveness Act - reauthorization of research and development tax credit
HR 5, S 218 Help Efficient, Accessible, Low-cost, Timely Healthcare Act - provisions relating to various medical malpractice and civil justice reforms HR 605, S 312 Patients Freedom to Choose Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2011 · first_quarter · Q1
HR 942 American Research and Competitiveness Act - reauthorization of research and development tax credit HR 605, S 312 Patients Freedom to Choose Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts
HR 1, H Res 92 Fiscal Year 2011 Continuing Resolution - provisions pertaining to Ryan White CARE Act, FDA funding HR 1473 The Department of Defense and Full Year Continuing Appropriations Act - provisions pertaining to Ryan White CARE Act, FDA funding Fiscal Year 2012 Labor-HHS-Education Appropriations (currently unassigned) - FY 2012 HHS Budget Request; proposal relating to Vaccine Section 317 program, Ryan White CARE Act PL 111-148, PL 111-152 Patient Protection and Affordable Care Act - FY 2011 Prevention and Public Health Fund; allocations for Vaccine Section 317 program and smoking cessation programs
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2011 · second_quarter · RA
PHARMACEUTICALS
PHARMACEUTICALS
PHARMACEUTICALS
PHARMACEUTICALS
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2010 · fourth_quarter · Q4
PL 111-148, PL 111-152 Patient Protection and Affordable Care Act - implementation, Independent Payment Advisory Board, comparative effectiveness research, health information technology, disease prevention/wellness and innovation provisions, biosimilars HR 759 Food and Drug Globalization Act of 2009 - drug safety HR 2892 Department of Homeland Security Appropriations Act, 2010 - drug importation and safety issues HR 5516 Access to Appropriate Immunizations for Veterans Act of 2010 - vaccine access HR 5923, S 3673 Patients' Freedom to Choose Act - use of FSA and HSA dollars for reimbursement of over-the-counter drugs HR 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 Secure and Responsible Drug Disposal Act - drug safety
HR 5503 Securing Protections for the Injured from Limitations on Liability Act - broader civil justice reform
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2010 · third_quarter · Q3
H.R. 422 To amend the Internal Revenue Code of 1986 to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit.
S.1003 Immunization Improvement Act of 2009 HR. 323 Comprehensive Insurance Coverage of Childhood Immunization Act of 2009
H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 882 Drug and Device Accountability Act of 2009 H.R. 1346 Medical Device Safety Act of 2009 S. 540 Medical Device Safety Act of 2009 H.R. 1508 Sunshine in Litigation Act of 2009 S.537 Sunshine in Litigation Act of 2009 S. 386 Fraud Enforcement and Recovery Act of 2009 S. 458 False Claims Act Clarification Act of 2009 H.R. 1298 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 1232 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 301 Physician Payments Sunshine Act of 2009 H.R. 1166 E-fencing Enforcement Act of 2009 H.R. 1173 Organized Retail Crime Act of 2009 S. 470 Combating Organized Retail Crime Act of 2009 H.R. 1788 False Claims Act Correction Act of 2009 H.R. 2892 Department of Homeland Security Appropriations, 2010 - provisions pertaining to Importation. H.R. 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 1504 Notice Pleading Restoration Act of 2009 S. 1679 Affordable Health Choices Act H.R. 3200 America's Affordable Health Choices Act of 2009 S. 1796 America's Affordable Health Choices Act of 2009 H.R. 3590 Patient Protection and Affordable Care Act America's Healthy Future Act of 2009 H.R. 3974 Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 H.R. 2596 No Child Left Unimmunized Against Influenza Act of 2009 S. 2964 Strengthening Program Integrity and Accountability in Health Care Act S. 3002 Dietary Supplement Safety Act of 2010 H.R. 4872 Health Care and Education Affordability Reconciliation Act H.R. 5516 Access to Appropriate Immunizations for Veterans Act of 2010 H.R. 5503 Securing Protections for the Injured from Limitations on Liability Act H.R. 4899 Supplemental Appropriations Act, 2010 - provisions pertaining to Bio-defense funding and the Ryan White CARE Act S. 3686 Fiscal Year 2011 Labor HHS Appropriations, all provisions pertaining to the Ryan White CARE Act as well as related House Fiscal Year 2011 Labor-HHS Appropriations Ryan White CARE Act provisions H.R. 5923 Patients Freedom to Choose Act, reimbursement of OTC drugs under Flexible and Health Savings accounts S. 3673 Patients Freedom to Choose Act, reimbursement of OTC drugs under Flexible and Health Savings accounts S. 3397 Secure and Responsible Drug Disposal Act, drug safety
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2010 · second_quarter · Q2
H.R. 5175 Democracy is Strengthened by Casting Light on Spending in Elections Act S. 3295 Democracy is Strengthened by Casting Light on Spending in Elections Act
H.R. 1427 Promoting Innovation and Access to Life-Saving Medicine Act of 2009 S. 726 Promoting Innovation and Access to Life-saving Medicine Act of 2009 H.R. 1548 The Pathway for Biosimilars Act of 2009 Food and Drug Administration's oversight and review of drug safety
S.1003 Immunization Improvement Act of 2009 HR. 323 Comprehensive Insurance Coverage of Childhood Immunization Act of 2009
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2010 · first_quarter · Q1
H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 882 Drug and Device Accountability Act of 2009 H.R. 1346 Medical Device Safety Act of 2009 S. 540 Medical Device Safety Act of 2009 H.R. 1508 Sunshine in Litigation Act of 2009 S.537 Sunshine in Litigation Act of 2009 S. 386 Fraud Enforcement and Recovery Act of 2009 S. 458 False Claims Act Clarification Act of 2009 H.R. 1298 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 1232 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 301 Physician Payments Sunshine Act of 2009 H.R. 1166 E-fencing Enforcement Act of 2009 H.R. 1173 Organized Retail Crime Act of 2009 S. 470 Combating Organized Retail Crime Act of 2009 H.R. 1788 False Claims Act Correction Act of 2009 H.R. 2892 Department of Homeland Security Appropriations, 2010 - provisions pertaining to Importation. H.R. 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 1504 Notice Pleading Restoration Act of 2009 S. 1679 Affordable Health Choices Act H.R. 3200 America's Affordable Health Choices Act of 2009 S. 1796 America's Affordable Health Choices Act of 2009 H.R. 3590 Patient Protection and Affordable Care Act America's Healthy Future Act of 2009 H.R. 3974 Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 H.R. 2596 No Child Left Unimmunized Against Influenza Act of 2009 S. 2964 Strengthening Program Integrity and Accountability in Health Care Act S. 3002 Dietary Supplement Safety Act of 2010 H.R. 4872 Health Care and Education Affordability Reconciliation Act
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2009 · fourth_quarter · Q4
S.1003 Immunization Improvement Act of 2009 HR. 323 Comprehensive Insurance Coverage of Childhood Immunization Act of 2009
S. 515 Patent Reform Act of 2009 S. 610 Patent Reform Act of 2009 H.R. 1250 Patent Reform Act of 2009 S. 369 Preserve Access to Affordable Generics Act H.R. 1706 Protecting Consumer Access to Generic Drugs Act of 2009
H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 882 Drug and Device Accountability Act of 2009 H.R. 1346 Medical Device Safety Act of 2009 S. 540 Medical Device Safety Act of 2009 H.R. 1508 Sunshine in Litigation Act of 2009 S.537 Sunshine in Litigation Act of 2009 S. 386 Fraud Enforcement and Recovery Act of 2009 S. 458 False Claims Act Clarification Act of 2009 H.R. 1298 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 1232 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 301 Physician Payments Sunshine Act of 2009 H.R. 1166 E-fencing Enforcement Act of 2009 H.R. 1173 Organized Retail Crime Act of 2009 S. 470 Combating Organized Retail Crime Act of 2009 H.R. 1788 False Claims Act Correction Act of 2009 H.R. 2892 Department of Homeland Security Appropriations, 2010 - provisions pertaining to Importation. H.R. 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 1504 Notice Pleading Restoration Act of 2009 S. 1679 Affordable Health Choices Act H.R. 3200 America's Affordable Health Choices Act of 2009 S. 1796 America's Affordable Health Choices Act of 2009 H.R. 3590 Patient Protection and Affordable Care Act America's Healthy Future Act of 2009
GSK (FKA GLAXOSMITHKLINE INC.) via GSK (FKA GLAXOSMITHKLINE INC.)
2009 · third_quarter · Q3
S.1003 Immunization Improvement Act of 2009 HR. 323 Comprehensive Insurance Coverage of Childhood Immunization Act of 2009
H.R. 1427 Promoting Innovation and Access to Life-Saving Medicine Act of 2009 S. 726 Promoting Innovation and Access to Life-saving Medicine Act of 2009 H.R. 1548 The Pathway for Biosimilars Act of 2009 H.R. 3293 Fiscal Year 2010 Labor, Health and Human Services and Education and Related Agencies - provisions pertaining to AIDS Drug Assistance Program (ADAP)
H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 882 Drug and Device Accountability Act of 2009 H.R. 1346 Medical Device Safety Act of 2009 S. 540 Medical Device Safety Act of 2009 H.R. 1508 Sunshine in Litigation Act of 2009 S.537 Sunshine in Litigation Act of 2009 S. 386 Fraud Enforcement and Recovery Act of 2009 S. 458 False Claims Act Clarification Act of 2009 H.R. 1298 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 1232 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 301 Physician Payments Sunshine Act of 2009 H.R. 1166 E-fencing Enforcement Act of 2009 H.R. 1173 Organized Retail Crime Act of 2009 S. 470 Combating Organized Retail Crime Act of 2009 H.R. 1788 False Claims Act Correction Act of 2009 H.R. 2892 Department of Homeland Security Appropriations, 2010 - provisions pertaining to Importation. H.R. 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 1504 Notice Pleading Restoration Act of 2009 S. 1679 Affordable Health Choices Act H.R. 3200 America's Affordable Health Choices Act of 2009 America's Healthy Future Act of 2009
H.R. 942 - American Research and Competitiveness Act of 2011- provisions relating to the research and development tax credit
S 2236 - Advancing Breakthrough Therapies for Patients Act of 2012 - provisions related to FDA regulation S 2113 - Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act - provisions related to accelerated approval and other FDA matters The Better Pharmaceuticals and Devices for Children Act - "Provisions related to o amending the Federal Food, Drug, and Cosmetic Act with respect to pediatric provisions" HR 4272 - BPCA and PREA Reauthorization Act of 2012 - Provisions related to amending title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act HR 4156, S 2281 - Expanding and Promoting Expertise in Rare Treatments Act of 2012 - provisions related to strengthening the FDA's ability to seek advice from external experts regarding rare diseases HR 3214 - Food and Drug Administration Mission Reform Act of 2011- provisions to revise the mission of the Food and Drug Administration HR 4132 - FAST Act - provisions related to accelerated approval and other FDA matters HR 3839 - Drug Shortage Prevention Act of 2012 - provisions related to prescription drug shortages HR 2674 - 340B Program Improvement Act - provisions related to the 340B program PL 111-148, PL 111-152 - Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 - Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies HR 4223, S 1002 - Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) - provisions related to supply chain security HR 1483 - The Drug Safety Enhancement Act of 2011 - provisions related to supply chain security HR 1930, S 1799 - Access to Appropriate Immunizations for Veterans Act of 2011- provisions related to extending VA performance measure to include all federally recommended vaccine HR 3202 - Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 - Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 - Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 - Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 - Pharmaceutical Stewardship Act of 2011- provisions related to drug safety Prescription Drug User Fee Act - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 - Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 - Drug Safety and Accountability Act of 2011- provisions related to drug safety Federal Food, Drug, and Cosmetic Act - section related to FDA and regulation of nicotine replacement therapies S. 1699 - Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 - Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
HR 3995 - Protect Consumers Access to Generic Drugs Act - provisions related to patent settlements S. 1882 - Fair and Immediate Release of Generic Drugs Act - provisions related to patent settlements HR 3497 - MODDERN Cures Act of 2011 - provisions related to data protection S 27 - Preserve Access to Affordable Generics Act - provisions related to patent settlements H.R. 741 - To amend the Federal Food, Drug and Cosmetic Act to prohibit the marketing of authorized generic drugs - provisions relating to authorized generics HR 3261 - Stop Online Piracy Act - provisions related to anti-counterfeiting S 373 - The Fair Prescription Drug Competition Act - provisions related to authorized generics S 968 - Preventing Online Threats to Economic Creativity and Theft of Intellectual Property Act of 2011 - provisions related to anti-counterfeiting HR 2182,S 1734 - Generating Antibiotic Incentives Now Act of 2011- provisions related to antibiotics and incentives
S 1699 - Prescription Drug Cost Reduction Act - provisions related to Medicare Part B and drug rebates HR 999 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 - Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 - Medicare Prescription Drug Price Negotiation Act of 2011- provision related to Medicare Part D HR 3765 - Temporary Payroll Tax Cut Continuation Act of 2011- provisions related to Medicare S 31 - Prescription Drug and Health Improvement Act of 2011-provisions related to Medicare Part D S 44 - Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 - Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) H.R. 5 - To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system - provisions related to the Independent Payment Advisory Board (IPAB) S 560 - Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 - Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 - Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D S 1251 - Medicare and Medicaid FAST Act - provisions related to Part D issues H.R. 1063 - Strengthening Medicare & Repaying Taxpayers Act of 2011 - provisions relating to reform of Secondary Payer rules S 365 - Budget Control Act of 2011 - provisions related to deficit reduction through Medicare and Medicaid
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PL 111-148, PL 111-152Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 2405, S 1855 Pandemic and All Hazards Preparedness Act - provisions relating to influenza vaccine innovative technologies S 1002 Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES)drug safety HR 1483 The Drug Safety Enhancement Act of 2011 - drug safety standards HR 1930, S 1799 Access to Appropriate Immunizations for Veterans Act of 2011 - extending VA performance measure to include all federally recommended vaccine HR 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S 3397 Secure and Responsible Drug Disposal Act - provisions related to safe drug disposal S 319 Pharmaceutical Market Access and Drug Safety Act of 2011 - provisions related to drug importation HR 2245, S 296 Preserving Access to Life-Savings Medicines Act of 2011 - provisions related to drug shortages HR 2939 Pharmaceutical Stewardship Act of 2011 - provisions related to drug safety ADDENDUM/General Lobbying Issue Area - Prescription Drug User Fee Act (currently unassigned) - issues related to reauthorization of the Prescription Drug User Fee Act HR 2529, S 1368 Restoring Access to Medication Act - provisions relating to reimbursement of OTC drugs under flexible spending and health savings accounts S 1584 Drug Safety and Accountability Act of 2011- provisions related to drug safety ADDENDUM/General Lobbying Issue Area - Federal Food, Drug, and Cosmetic Act (currently unassigned) - section related to FDA and regulation of nicotine replacement therapies S. 1699 Prescription Drug Cost Reduction Act - provisions related to 340B and drug rebates S. 1752 Freedom to Breath Act of 2011 - provisions relating to the removal of Essential-Use Designation for epinephrine.
HR 942American Research and Competitiveness Act of 2011provisions relating to the research and development tax credit
HR 2112 Fiscal Year 2012 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act - provisions pertaining to Ryan White CARE Act, FDA funding HR 2017 The Department of Homeland Security Appropriations Act - provisions pertaining to Customs and Border Protection HR 2608 Fiscal Year 2012 Continuing Appropriations Act - FDA funding and related provisions S 1599 Fiscal Year 2012 Labor-HHS-Education Appropriations; FY 2012 HHS Budget Request; provisions relating to Vaccine Section 317 program, Ryan White CARE Act HR 2055 Fiscal Year 2012 Consolidated Appropriations Act - provisions relating to health and trade
HR 3080Korea Free Trade Agreement - provisions related to intellectual property, market access and public health Trans-Pacific Strategic Economic Partnership Agreement (TPP) - provisions related to intellectual property, market access and public health
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
HR 999 Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D HR 2190 Medicare Drug Savings Act of 2011- provisions related to Medicare Part D HR 2248 Medicare Prescription Drug Price Negotiation Act of 2011 - provision related to Medicare Part D S 31 Prescription Drug and Health Improvement Act of 2011 - provisions related to Medicare Part D S 44 Medicare Prescription Drug Price Negotiation Act of 2011- provisions related to Medicare Part D HR 452 Medicare Decisions Accountability Act - provisions related to the Independent Payment Advisory Board (IPAB) S 365 Budget Control Act of 2011- deficit reduction issues related to Medicare and Medicaid S 560 Medicare Prescription Drug Savings and Choice Act of 2011- provisions related to Medicare Part D S 668 Health Care Bureaucrats Elimination Act - provisions related to the Independent Payment Advisory Board (IPAB) S 1206 Medicare Prescription Drug Savings Act of 2011- provisions related to Medicare Part D
S 23, HR 1249 America Invents Act - provisions related to supplemental examination, first inventor to file, best mode, and false marking S 27 Preserve Access to Affordable Generics Act - provisions related to patent settlements HR 1056 Patent Continuing Disclosure Act - provisions related to false patent marking HR 243, S 515 Patent Lawsuit Reform Act of 2011 - provisions related to false patent marking
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
PL 111-148, PL 111-152 Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 452 Medicare Decisions Accountability Act - repeal of Independent Payment Advisory Board (IPAB) S 668 Health Care Bureaucrats Elimination Act - repeal of Independent Payment Advisory Board (IPAB) HR 1930 Access to Appropriate Immunizations for Veterans Act of 2011- extending VA performance measures to include all federally recommended vaccines HR 2405 Pandemic and All Hazards Preparedness Act - Re-authorization; influenza vaccine innovative technologies S 1002 Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act (SAFE DOSES) drug safety HR 1483 The Drug Safety Enhancement Act of 2011- drug safety standards HR 2182 Generating Antibiotic Incentives Now Act of 2011Provisions related to antibiotics and incentives ADDENDUM/General Lobbying Issue Area - Federal Food, Drug, and Cosmetic Act (currently unassigned) - section related to FDA and regulation of nicotine replacement therapies
HR 2112 Fiscal Year 2012 Agriculture Appropriations - provisions pertaining to Ryan White CARE Act, FDA funding HR 1473 The Department of Defense and Full Year Continuing Appropriations Act - provisions pertaining to Ryan White CARE Act, FDA funding Fiscal Year 2012 Labor-HHS-Education Appropriations - FY 2012 HHS Budget Request; proposal relating to Vaccine Section 317 program, Ryan White CARE Act PL 111-148, PL 111-152 Patient Protection and Affordable Care Act - FY 2011 Prevention and Public Health Fund; allocations for Vaccine Section 317 program and smoking cessation programs HR 2190, S 1206Medicare Drug Savings ActMedicare drug rebates
PL 111-148, PL 111-152 Patient Protection and Affordable Care Act - Medicare and Medicaid payment, Medicare Part D coverage gap, 340B drug pricing, meaningful use Part D benefit; quality measures; COPD maintenance treatment
ADDENDUM/General Lobbying Issue Area - Prescription Drug User Fee Act PDUFA-V (currently unassigned) - issues related to reauthorization of the Prescription Drug User Fee Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
HR 5, S 218 Help Efficient, Accessible, Low-cost, Timely Healthcare Act - provisions relating to various medical malpractice and civil justice reforms
HR 675 Strengthening Medicare Anti-Fraud Measures Act - provisions relating to HHS OIG debarment authority Congressional education - GSK's Corporate Social Responsibility Report
S 23 Patent Reform Act of 2011 - provisions related to supplemental examination, first inventor to file, best mode, and false marking HR 1249 America Invents Act - provisions related to supplemental examination, first inventor to file, best mode, and false marking
PL 111-148, PL 111-152 Patient Protection and Affordable Care Act - ACA implementation, Independent Payment Advisory Board (IPAB), comparative effectiveness, health information technology, disease prevention/wellness, sunshine and innovation provisions HR 452 Medicare Decisions Accountability Act - repeal of Independent Payment Advisory Board (IPAB) S 668 Health Care Bureaucrats Elimination Act - repeal of Independent Payment Advisory Board (IPAB) S 296 Preserving Access to Life-Saving Medications Act - provisions related to drug access, drug pricing, generics and the FDA S 223 FAA Air Transportation Modernization and Safety Improvement Act - amendments related to Patient Protection and Affordable Care Act S 319 Pharmaceutical Market Access and Drug Safety Act of 2011 - drug safety and importation Access to Appropriate Immunizations for Veterans Act (currently unassigned) - reintroduction of HR 5516 in 112th Congress Federal Food, Drug, and Cosmetic Act (currently unassigned) - section related to FDA and regulation of nicotine replacement therapies Prescription Drug User Fee Act PDUFA-V (currently unassigned) - issues related to reauthorization of the Prescription Drug User Fee Act
PL 111-148, PL 111-152 Patient Protection and Affordable Care Act - Medicare and Medicaid payment, Medicare Part D coverage gap, 340B drug pricing, meaningful use
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
PHARMACEUTICALS
PHARMACEUTICALS
PHARMACEUTICALS
HR 5175, S 3295 Democracy is Strengthened by Casting Light on Spending in Elections Act - campaign finance, treatment of US subsidiaries
HR 4899 Supplemental Appropriations Act, 2010 - bio-defense funding and the Ryan White CARE Act S 3686 FY 2011 Labor, HHS, Education and Related Agencies Appropriations - immunization funding and the Ryan White CARE Act HR 3082, SA 4887 (enacted PL 111-322) Continuing Appropriations Act, 2011 - provisions pertaining to Ryan White CARE Act
HR 4853 Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010 - R&D tax credit HR 422 Heart Disease Education, Analysis Research, and Treatment for Women Act - R&D tax credit
HR 1260, S 515 Patent Reform Act of 2009 - patent law reform S 369 Preserve Access to Affordable Generics Act - patent settlements
PL 111-148, PL 111-152 Patient Protection and Affordable Care Act - Medicare and Medicaid payment, Medicare Part D coverage gap, 340B drug pricing
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
S. 515 Patent Reform Act of 2009 and the Manager's Amendment H.R. 1250 Patent Reform Act of 2009 S. 369 Preserve Access to Affordable Generics Act H.R. 1706 Protecting Consumer Access to Generic Drugs Act of 2009 H.R. 5322 Patent and Trademark Office Funding Stabilization Act of 2010
H.R. 5175 Democracy is Strengthened by Casting Light on Spending in Elections Act S. 3295 Democracy is Strengthened by Casting Light on Spending in Elections Act
H.R. 1427 Promoting Innovation and Access to Life-Saving Medicine Act of 2009 S. 726 Promoting Innovation and Access to Life-saving Medicine Act of 2009 H.R. 1548 The Pathway for Biosimilars Act of 2009 Food and Drug Administration's oversight and review of drug safety
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
S. 515 Patent Reform Act of 2009 and the Manager's Amendment H.R. 1250 Patent Reform Act of 2009 S. 369 Preserve Access to Affordable Generics Act H.R. 1706 Protecting Consumer Access to Generic Drugs Act of 2009 H.R. 5322 Patent and Trademark Office Funding Stabilization Act of 2010
H.R. 422 To amend the Internal Revenue Code of 1986 to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit.
H.R. 759 Food and Drug Administration Globalization Act of 2009 S. 882 Drug and Device Accountability Act of 2009 H.R. 1346 Medical Device Safety Act of 2009 S. 540 Medical Device Safety Act of 2009 H.R. 1508 Sunshine in Litigation Act of 2009 S.537 Sunshine in Litigation Act of 2009 S. 386 Fraud Enforcement and Recovery Act of 2009 S. 458 False Claims Act Clarification Act of 2009 H.R. 1298 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 525 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 1232 Pharmaceutical Market Access and Drug Safety Act of 2009 S. 301 Physician Payments Sunshine Act of 2009 H.R. 1166 E-fencing Enforcement Act of 2009 H.R. 1173 Organized Retail Crime Act of 2009 S. 470 Combating Organized Retail Crime Act of 2009 H.R. 1788 False Claims Act Correction Act of 2009 H.R. 2892 Department of Homeland Security Appropriations, 2010 - provisions pertaining to Importation. H.R. 3202 Water Protection and Reinvestment Act - provisions pertaining to pharmaceuticals in the environment S. 1504 Notice Pleading Restoration Act of 2009 S. 1679 Affordable Health Choices Act H.R. 3200 America's Affordable Health Choices Act of 2009 S. 1796 America's Affordable Health Choices Act of 2009 H.R. 3590 Patient Protection and Affordable Care Act America's Healthy Future Act of 2009 H.R. 3974 Viral Hepatitis and Liver Cancer Control and Prevention Act of 2009 H.R. 2596 No Child Left Unimmunized Against Influenza Act of 2009 S. 2964 Strengthening Program Integrity and Accountability in Health Care Act S. 3002 Dietary Supplement Safety Act of 2010 H.R. 4872 Health Care and Education Affordability Reconciliation Act H.R. 5516 Access to Appropriate Immunizations for Veterans Act of 2010 H.R. 5503 Securing Protections for the Injured from Limitations on Liability Act H.R. 4899 Supplemental Appropriations Act, 2010 - provisions pertaining to Bio-defense funding and the Ryan White CARE Act Fiscal Year 2011 Labor, Health and Human Services Appropriations - provisions pertaining to the Ryan White CARE Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
H.R. 422 To amend the Internal Revenue Code of 1986 to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit.
H.R. 1427 Promoting Innovation and Access to Life-Saving Medicine Act of 2009 S. 726 Promoting Innovation and Access to Life-saving Medicine Act of 2009 H.R. 1548 The Pathway for Biosimilars Act of 2009 H.R. 3293 Fiscal Year 2010 Labor, Health and Human Services and Education and Related Agencies - provisions pertaining to AIDS Drug Assistance Program (ADAP)
S.1003 Immunization Improvement Act of 2009 HR. 323 Comprehensive Insurance Coverage of Childhood Immunization Act of 2009
S. 515 Patent Reform Act of 2009 H.R. 1250 Patent Reform Act of 2009 S. 369 Preserve Access to Affordable Generics Act H.R. 1706 Protecting Consumer Access to Generic Drugs Act of 2009
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
H.R. 422 To amend the Internal Revenue Code of 1986 to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit.
H.R. 1427 Promoting Innovation and Access to Life-Saving Medicine Act of 2009 S. 726 Promoting Innovation and Access to Life-saving Medicine Act of 2009 H.R. 1548 The Pathway for Biosimilars Act of 2009 H.R. 3293 Fiscal Year 2010 Labor, Health and Human Services and Education and Related Agencies - provisions pertaining to AIDS Drug Assistance Program (ADAP)
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
S. 515 Patent Reform Act of 2009 S. 610 Patent Reform Act of 2009 H.R. 1250 Patent Reform Act of 2009 S. 369 Preserve Access to Affordable Generics Act H.R. 1706 Protecting Consumer Access to Generic Drugs Act of 2009
H.R. 422 To amend the Internal Revenue Code of 1986 to extend the research credit through 2010 and to increase and make permanent the alternative simplified research credit.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE